BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522232 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00025
    Event Type
    Injury
    Date Received
    November 2, 2009
    Report Date
    October 19, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K051065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED OFF-LABEL: THE ORTHADAPT BIOIMPLANT IS NOT INDICATED FOR USE IN METATARSALPHALANGEAL JOINT REPAIR. PHYSICIAN INDICATES THAT THE PT HAS SEVERE ATROPHY AT THE JOINT AND THE REPORTED ISSUES ARE NOT RELATED TO THE ORTHADAPT BIOIMPLANT. THE MFG LOT AND EXPIRATION DATE OF THE DEVICE WERE NOT PROVIDED. THE MFR OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC. SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR WEEKS POST- 1ST METATARSALPHALENGEAL JOINT REPAIR WITH ORTHADAPT AUGMENTATION, THE PT EXPERIENCED SWELLING AT THE PLANTAR SIDE OF THE JOINT AS WELL AS SYNOVIAL FLUID DRAINAGE FROM THE DORSAL JOINT. THE GRAFT WAS EXPLANTED APPROXIMATELY SIX WEEKS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization